Policies & Procedures DRUG DISCOVERY AND DEVELOPMENT GRADUATE PROGRAM

advertisement
DRUG DISCOVERY AND DEVELOPMENT
GRADUATE PROGRAM
Policies & Procedures
*Please note that these policies are subject to change; students will be notified of any
changes.
Department of Pharmacology & Physiology
Graduate Program in Drug Discovery & Development
Drexel University College of Medicine
Room 8304, NCB
245 N. 15th Street
Philadelphia, PA 19102
TEL: 215-762-4530
FAX: 215-762-4850
Revised: 8/2014
1
TABLE OF CONTENTS
Pages
I. INTRODUCTION
3
II. OBJECTIVES
3
III. BASIC GUIDELINES FOR MS DEGREE
3
A. Course Requirements
3
B. Curriculum
4
C. Laboratory Rotations
5
D. Elective Courses
5
1. College of Medicine
2. School of Biomedical Engineering
3. School of Public Health
4. LeBow College of Business
5. Professional Studies Program
6
6
6
7
7
E. Internships
7
IV. THESIS TRACK
7
A. Thesis Requirements
7
B. Thesis Advisory Committee
7
C. Thesis Proposal
8
D. Thesis Defense
8
V. NON-THESIS TRACK
9
A. Course Requirements
9
B. Scholarly Review
9
C. Advisory Committee
9
D. Review Proposal
10
E. Review Evaluation
10
CODE OF BEHAVIOR
11
CODE OF ETHICS
11
I. INTRODUCTION
2
The Graduate Program offers coursework and research opportunities leading to the MS degree in Drug
Discovery and Development. The overall goal of this Program is to provide students with an intensive
multifaceted classroom experience along with diverse research avenues to prepare graduates for career
opportunities in the pharmaceutical and biotech industries. There are several requirements that are
necessary to obtain a MS degree in this program and they are described below.
The Program’s foundation is in the biomedical sciences with an initial emphasis on the disciplines of
Pharmacology and Physiology. A main concentration will be on providing an in-depth focus on the
detailed and complex processes involved in drug discovery and development. The program includes
resident faculty from the Department of Pharmacology & Physiology and other programs, faculty with
experience in the pharmaceutical and biotechnology industry, as well as scientists and executives from
various pharmaceutical and biotechnology companies. The Program will cover all aspects involved in the
discovery, development and commercialization of drugs. Depending on a student’s preferences, there are
multiple options and areas of concentration that can be pursued using elective courses in different
departments, schools and colleges.
This booklet describes academic policies and procedures pertaining to graduate study in the Drug
Discovery and Development Graduate Program. The information in this booklet supplements procedures
and general rules of the Office of Biomedical Graduate Studies and contains current guidelines that are
revised periodically by faculty in the Program.
II. OBJECTIVES
The purpose of this Program is to provide academic training and research opportunities enabling
in-depth exposure to the multiple elements associated with drug discovery and development. By
increasing one’s knowledge in this area, this Program will provide additional career options to
graduating students. This degree will also be available to individuals seeking to better understand
as well as increase their base of knowledge in this area to enhance their career advancement
opportunities. The Program has been designed with the recognition that the pharmaceutical and
biotechnology industries are complex, are constantly evolving, and require a diversity of
expertise. We have tapped into the rich and diverse resources available within the Drexel
University academic community to draw on courses available in the LeBow School of Business,
the School of Public Health and other departments and schools and have also successfully
attracted individuals from all levels and sectors of the pharmaceutical industry to participate in
the development of the program. This Program will provide students with a core, detailed focus
on the many facets of Drug Discovery and Development while simultaneously providing those
students with multiple options to pursue related areas of interest.
III. BASIC GUIDELINES FOR THE MS DEGREE
A. Course Requirements
All students in the Drug Discovery and Development Program are required to take the following
programmatic courses in the first year: Drug Discovery and Development I and II, Graduate
Physiology, and Advanced Topics in Physiology. In the second year, students must take
Graduate Pharmacology and Advanced Topics in Pharmacology. In addition, students must take
Scientific Integrity and Ethics and Biostatistics or Statistics for Neuro/Pharm Research. All
students must register and participate in the seminar/discussion course (Journal Club) Current
Topics in Pharmacology and Physiology every semester while in the program up until registering
for Thesis Defense. It is expected that each student will complete at least one research rotation
3
in Drug Discovery and Development Research. The Program Director will advise each student
on the selection of the flexible aspects of the curriculum such as choice of electives.
B. Curriculum
First Year Fall Semester
PHRM-525 Drug Discovery and Development I
PHGY-503 Graduate Physiology
PHRM-518 Advanced Topics in Physiology
IDPT-500
Responsible Conduct of Research
PHRM-502 Current Topics in Pharmacology & Physiology
Total credits:
3 credits
4 credits
1 credits
2 credits
1 credit
11 credits
First Year Spring Semester
PHRM-526 Drug Discovery and Development II
NEUR-500 Statistics for Neuro/Pharm Research*
PHRM-504 Research in Drug Discovery and Development
PHRM-502 Current Topics in Pharmacology & Physiology
Elective
Total credits:
3 credits
2 credits
4 credits
1 credits
3 credits
13 credits
The Drug Discovery and Development Program Director will serve as Advisor to New Graduate
Students and meet with them once during the Fall and Spring semesters of the first year of study.
*Statistics requirement may be met by taking Biostatistics (IDPT-501).
Second Year Fall Semester
PHRM-512 Graduate Pharmacology
PHRM-516 Advanced Topics in Pharmacology
PHRM-502 Current Topics in Pharmacology & Physiology
Elective 1
Elective 2
Total credits:
Second Year Spring Semester
PHRM-600 Pharmacology & Physiology Thesis Research
OR
PHRM-520 Internship in Drug Discovery and Development
PHRM-503 Pharmacology & Physiology Lab Rotation
PHRM-502 Current Topics in Pharmacology & Physiology
Total credits:
4
3 credits
1 credits
1 credits
3 credit
4 credits
12 credits
9 credits
4 credits
4 credits
1 credit
9 credits
^The student is required to take 2 graduate level elective courses chosen with advice from the
Program Director and/or the Research Advisor.
The Office of Biomedical Education has established criteria by which all students in all graduate
programs will be uniformly evaluated. A grade of B must be earned in each required course.
Programmatic courses must be repeated if the student earns a grade below a B in that particular
course. Programmatic courses in which a student has earned a grade of B- can be remediated to a
B. Students must maintain a grade point average of at least 3.0. If their average falls below 3.0,
they will automatically be placed on academic probation.
Performance Criteria for Current Topics in Pharmacology & Physiology
Three unexcused absences are allowed per year for journal clubs. More than three absences will
result in a grade of Unsatisfactory (U). The “U” must be remediated to the satisfaction of the
course director.
C. Laboratory Rotations
Laboratory rotations must be arranged in consultation with the Program Director and faculty of
the Program. The research areas may be chosen to complement the student's long-term research
interests. Research rotations should provide an opportunity to:
•
•
•
•
•
Practice scientific logic and experimental design
Acquire useful technical expertise
Extend scientific and personal interactions within and between labs
Explore the possibility for a future Thesis research topic
Develop presentation skills
At least 20 hours per week (minimum) for a three-month period are required for each rotation.
An oral presentation of the research experience is prepared by the student at the end of each
rotation, presented to the department and evaluated by the faculty and the student. Students must
complete a rotation evaluation form with their mentor upon completion of their rotation which
must be filed with the Program Director and the Biomedical Graduate Studies office.
Performance Criteria for Laboratory Rotations
Laboratory rotations are graded on a Satisfactory (S) or Unsatisfactory (U) basis. Students
receiving an “S” are rated on a performance scale ranging from Outstanding (1) to Poor (5). A
“U” for a lab rotation is reserved for students that do not meet performance requirements,
including attendance, of the rotation as stipulated by the program.
D. Elective Courses
In consultation with the student’s advisor and according to the anticipated area of interest, the
student is required to select a minimum of 2 elective courses from a diverse range of topics that
complement the core curriculum and which provide relevant, in-depth knowledge to enhance
career options. The two elective courses can be taken as appropriate throughout the student’s
training. Courses outside of the Drug Discovery and Development program may be taken on the advice
and with the permission of the Program Director and the faculty mentor.
5
A list of potential electives is provided below. This is a representative list and students are not
limited to selecting from this list of electives. It is recommended that you consult with the course
director for each course to receive approval to register for the course and to determine if there are
prerequisites or class limitations. For courses outside the College of Medicine, please consult the
Graduate catalog at http://catalog.drexel.edu/coursedescriptions/quarter/grad/
Advanced Elective Courses:
1. College of Medicine
credits
Pharmacology & Physiology
PHRM-516 Methods in Biomedical Research
PHRM-520 Internship in Drug Discovery and Development
PHRM-518 New Frontiers in Therapy
PHRM-507 Principles of Neuropharmacology
PHRM-503 Pharmacology & Physiology Lab Rotation
3
4
3
3
4
Neuroscience
NEUR-512
NEUR-508
1.5
2.5
Advanced Cellular & Systems Neurophysiology
Graduate Neuroscience I
Microbiology & Immunology
MIIM-630
Advanced Molecular Biology
MIIM-521
Biotechniques
MIIM-613
Emerging Infectious Diseases
MIIM-530
Fundamentals of Molecular Medicine I
MIIM-531
Fundamentals of Molecular Medicine II
MIIM-508
Immunology I
MIIM-512
Molecular Pathogenesis I
MIIM-524
Vaccines & Vaccine Development
2
2*
2
2-3
2
3
3
3*
Biochemistry
BIOC-510
3
Cancer Biology
Molecular Pathobiology
PATH-601
Cell & Molecular Biology of Cancer
4
2. School of Biomedical Engineering & Health Sciences
BMES-588
BMES-604
BIO-631
Medical Device Development
Pharmacogenomics
Bioinformatics
3
3
3
Introduction to Public Health
Principles of Epidemiology
2
4
3. School of Public Health
PBHL-516
PBHL-530
6
4. LeBow College of Business
BUSN-601
BUSN-602
MGMT-685
MGMT-910
PROJ-501
PROJ-535
MGMT-940
ORGB-625
Health Care Law and Pharmaceutical Regulations
Business Strategies in Drug Development
Implementing Strategies Using Project Teams
Readings in Strategic Management
Introduction to Project Management
International Project Management
Seminar in Organizational Behavior
Leadership and Professional Development
3
3
3
3
3
3
3
3
5. Professional Studies Program
MLAS-536
Animal Models for Biomedical Research
1*
*Restrictions apply
NOTE: Courses in the Schools of Public Health and Biomedical Engineering & Health
Sciences as well as the LeBow College of Business are offered on a quarter, not
semester, schedule
E. Internships
An internship is a critical component of the training program in Drug Discovery and Development and
provides a unique opportunity for the student to apply the didactic knowledge gained in the laboratory in
a professional setting. The internship experience can be utilized to obtain specialized training in an
branch of the field that the student intends to pursue after graduation or it can provide valuable
diversification to a student’s background. Internships may be arranged with pharmaceutical companies,
biotech companies, contract research organizations, foundations, government agencies or academic
institutions. Several of these organizations have established formal internship or co-op programs that
would be appropriate for this experience. Students are expected to arrange an internship with the
assistance of the Program faculty to take place over the summer or during the Spring semester of their 2nd
year.
IV. THESIS TRACK
A. Thesis Requirement
The thesis project need not be independent but rather must be at the suggestion and guidance of the major
advisor. The project must be appropriate for completion and thesis defense no later than August of the
second year. Laboratory work can begin during the summer after the first year and continue through the
second year.
B. Thesis Advisory Committee
By the end of the third semester, the student will propose members of the faculty to serve on the
Thesis Advisory Committee subject to approval by the Program Director. Once formed, this
committee will meet every three months to review the student’s progress. The committee consists of at
least three voting members who must be Graduate School faculty from the Drug Discovery and
Development or Pharmacology & Physiology Graduate Programs. The student’s major advisor is a voting
member of the Committee but cannot chair the Committee. The Chair of the Committee must not be a
collaborator on the student’s research project and must not have any apparent conflicts of interest related
7
to the publication or funding of the student’s project. It is also the responsibility of the Chair to ensure
that there is sufficient balance on the committee to ensure a rigorous and unbiased critique of the
student’s project and progress. Following the quarterly review by the Committee, a brief statement of the
student’s progress must be signed by each Committee member and submitted to the Program Director.
C. Thesis Proposal
1. Master’s degree students will present their thesis proposal to their thesis advisory committee. The
Thesis Proposal document will be submitted by the student after completion of the Fall semester courses
of the 2nd year of study. Under special circumstances this can be extended (no more than 6 months but all
proposals for extensions will be given due consideration; approval must be obtained through written
request to the Program Director). The Thesis Proposal must include an abstract and planned table of
contents and be handed in one week prior to the formal presentation of the Thesis Proposal to his/her
Thesis Advisory Committee unless otherwise specified by the Chair of the Committee. Upon approval of
the Thesis Proposal the student will continue with his/her thesis research, culminating with the
presentation of the MS thesis for defense.
2. At the time of the proposal the student will present a brief (10-15 minute) oral summary of his/her
intended research project followed by a detailed question and answer session with the Thesis Advisory
Committee.
3. The Thesis Advisory Committee will then reach a decision. If the decision is positive, the student may
continue with his/her thesis research. If the decision is negative, the student can re-submit a revised or
new proposal in one month. If the Thesis Proposal is rejected a second time, the student will be
recommended for a non-thesis Master’s degree.
D. Thesis Defense
1. A written thesis is required with an oral defense before the thesis advisory committee. A candidate may
not present him/herself for the final thesis defense until he or she has completed at least 12 calendar
weeks of residence after satisfactory completion of the Thesis Proposal, and has the approval of his/her
major advisor.
2. At least four weeks prior to the date of the thesis defense, the Chair of the Committee, or the Program
Coordinator must notify the Office of Biomedical Graduate Studies, the Registrar’s Office and all
departments involved in graduate education of the scheduled date of the thesis defense. At least two
weeks prior to the date of the defense, typewritten or photocopies of the thesis must be distributed to each
member of the advisory-examination committee.
3. The thesis defense will take place no less than two weeks and no more than four weeks after the thesis
has been distributed to the members of the examination committee, except under written direction of the
Steering Committee.
4. The thesis defense will be public. The candidate will be formally introduced by his/her advisor or the
Chair of the Committee. The candidate will present a 30-minute seminar on his/her research, followed by
questions from the Examination Committee and the general audience. After this initial question and
answer period, the chair will dismiss the audience. The Examination Committee will meet in private with
the candidate to complete the examination process.
5. The Thesis Examination Committee shall decide upon the merits of the candidate’s performance on the
thesis defense. To be recommended for a Master’s degree, the candidate must receive unanimous
approval of the Committee. By permission of the Committee a candidate who has failed the final thesis
defense may present him or herself for re-examination after one, but not more than six months. This reexamination must be taken within a calendar year of failure to pass the first examination. A report on each
8
final thesis defense whether passed, failed, or recommended for re-examination must be filed by the
Committee in the Office of Biomedical Graduate Studies.
6. Three copies of the completed thesis suitable for binding and bearing the approval of the advisoryexamination Committee must be deposited in the Office of Biomedical Graduate Studies. One of these
copies is to be placed on file in the COM Library, Graduate Office and the Pharmacology & Physiology
Main Office. An unbound copy of the thesis must also be presented to the Office of Biomedical Graduate
Studies for microfilming by University Microfilms, Ann Arbor Michigan. The abstract will be published
in Dissertation Abstract by University Microfilms. The cost of preparation, reproduction and personal
binding copies are the candidate’s responsibility.
V NON-THESIS TRACK
A. Course Requirements
The Drug Discovery and Development Program offers a non-thesis MS degree in which students can earn
the degree by taking graduate classes and writing a literature review paper as opposed to conducting
original research. The requirements for a MS degree without thesis are essentially the same as those
described above except that preparation of a scholarly review is required in lieu of a research-based
thesis. The student is encouraged to choose a faculty or external mentor no later than the end of the Fall
semester of the second year. External mentors must be approved by the Program Director who will help
to insure that the student is making adequate progress. The role of the mentor is to provide guidance in
selecting the topic for the scholarly review, and in helping the student perform the literature search, and,
in writing the document. The selected topic must be approved by the Scholarly Review Advisory
Committee.
B. Scholarly Review
The scholarly review covers a topic in detail based on primary research literature. The body of the paper
must be 35-50 double spaced pages (12 pt font). This page number does not include citations but citations
must be provided as well. The following format must be followed:
•
Abstract (250 words)
•
Body of Paper
•
Introduction – what is the purpose and scope of the review
•
Literature review – review and contrast findings in the field; identify unresolved issues
and shortcomings of technical approaches
•
Summary – what are the key findings of the review
•
Conclusion- what gaps in our knowledge or unanswered questions emerge from the
review; what are potential future directions for research in this area.
Successful completion of the literature review will be subject to the approval of the mentor/advisor and
the Advisory Committee. The student is strongly encouraged to produce a document of sufficient quality
to merit consideration for publication.
C. Scholarly Review Advisory Committee
By the end of the third semester, the student will propose members of the faculty to serve on the
Advisory Committee subject to approval by the Program Director. Once formed, this committee will
meet every three months to review the student’s progress. The committee consists of at least three voting
members who must be Graduate School faculty from the Drug Discovery and Development or
9
Pharmacology & Physiology Graduate Programs. The student’s major advisor is a voting member of the
Committee but cannot chair the Committee. It is also the responsibility of the Chair to ensure that there is
sufficient balance on the committee to ensure a rigorous and unbiased critique of the student’s project and
progress. Following the quarterly review by the Committee, a brief statement of the student’s progress
must be signed by each Committee member and submitted to the Program Director.
D. Scholarly Review Proposal
1. Master’s degree students will present their Review Proposal to their advisory committee. The Proposal
document will be submitted by the student after completion of the Fall semester courses of the 2nd year of
study. Under special circumstances this can be extended (no more than 6 months but all proposals for
extensions will be given due consideration; approval must be obtained through written request to the
Program Director). The Review Proposal must include an abstract and planned table of contents and be
handed in one week prior to the formal presentation of the Proposal to his/her Advisory Committee unless
otherwise specified by the Chair of the Committee. Upon approval of the Proposal, the student will
continue with his/her literature research, culminating with the presentation of the Review.
2. At the time of the proposal the student will present a brief (10-15 minute) oral summary of his/her
intended Review followed by a detailed question and answer session with the Advisory Committee.
3. The Advisory Committee will then reach a decision. If the decision is positive, the student may
continue with his/her literature research. If the decision is negative, the student can re-submit a revised or
new proposal in one month.
E. Scholarly Review Evaluation
1. A written review is required with an oral presentation before the advisory committee. A candidate may
not present him/herself for the final presentation until he or she has completed at least 8 calendar weeks of
residence after satisfactory completion of the Proposal, and has the approval of his/her advisor.
2. At least two weeks prior to the date of the defense, typewritten or photocopies of the scholarly review
must be distributed to each member of the advisory committee.
3. The presentation will take place no less than two weeks and no more than four weeks after the written
review has been distributed to the members of the committee except under written direction of the
Program Director.
4. The presentation will be public. The candidate will be formally introduced by his/her advisor or the
Chair of the Committee. The candidate will present a 30-minute seminar on his/her review topic, followed
by questions from the Advisory Committee and the general audience. After this initial question and
answer period, the chair will dismiss the audience. The Advisory Committee will meet in private with the
candidate to complete the evaluation process.
5. The Advisory Committee shall decide upon the merits of the candidate’s performance on the
presentation and knowledge of the material. To be recommended for a Master’s degree, the candidate
must receive unanimous approval of the Committee. By permission of the Committee a candidate who
has failed the final evaluation may present him or herself for re-evaluation after one, but not more than six
months.
10
CODE OF BEHAVIOR
The Graduate Program in Pharmacology & Physiology subscribes to the Code of
Professionalism (http://www.drexelmed.edu/Portals/0/BiomedicalGraduateStudies
/StudentHandbook2010.pdf) for all of its members. This policy states that professional
behavior appropriate to a faculty and students in an academic research setting is
expected and required at all times. Admission to and continued participation in the
Graduate Program is therefore contingent upon the student's understanding of this
policy, and his/her agreement to adhere to its guidelines.
CODE OF ETHICS
The Graduate Program in Pharmacology & Physiology subscribes to the Code of
Academic Integrity (presented in its complete form in the Student Handbook,
(http://www.drexelmed.edu/Portals/0/BiomedicalGraduateStudies/StudentHandbo
ok2010.pdf) for all its members. This policy states that cheating, plagiarism, forgery, or
other forms of academic misconduct are not tolerated at our institution. Admission to
and continued participation in the Graduate Program is therefore contingent upon the
student's understanding of this policy, and his/her agreement to adhere to its guidelines.
11
Download